Esophageal treatment arrangement

ABSTRACT

Apparatus for the treatment of Barrett&#39;s esophagus, including: an inflatable balloon for insertion into the esophagus, an endoscope for passing inside the balloon on a distal end thereof, a laser fiber apparatus for insertion within the balloon in the esophagus, and a balloon inflation/deflation means in fluid communication with the balloon for inflating and emptying the balloon into and out of contact with the walls of the esophagus to be treated. The balloon may occlude the stomach from the esophagus during treatment.

BACKGROUND OF THE INVENTION FIELD OF THE INVENTION

[0001] This invention relates to the treatment of Esophageal Dysplasia,otherwise known as Barrett's Esophagus, based upon provisionalapplication serial No. 60/464,181, filed 21 Apr. 2003, and incorporatedby reference in its entirety.

PRIOR ART

[0002] Barrett's Esophagus is a pre-malignant condition of the mucosaassociated with gastroesophageal reflux disease (GERD). The term GERDrefers to the reflux of gastric acid fluids from the stomach into theswallowing tube or esophagus and is typically called “heartburn”.Barrett's Esophagus is typically diagnosed by an endoscopic examinationand biopsy wherein a tube equipped with imaging optics on its distal tipis inserted in a patient's mouth and into the esophagus to view andbiopsy the lining of the esophagus. An abnormal lining is seen as pinkor reddish (often described as salmon colored), which would replace anormal whiteish color of the lining of the esophagus. Such an abnormallining may cover a short distance, less than three inches, or a longerdistance of the esophagus from the gastroesophageal junction, that is,where the esophagus meets the stomach. A biopsy of the pinkish liningmay indicate the presence of intestinal type cells which are otherwisecalled goblet cells. The presence of such goblet cells indicates thelikelihood of Barrett's Esophagus. Barrett's tissue may also containdisorganized abnormal blood vessels which results in the lesion'scharacteristic color.

[0003] Dysplasia in Barrett's Esophagus is a change in the cells thatline the esophagus, wherein those cells actually appear abnormal. Thesecellular changes, or dysplasia may indicate a pre-cancerous condition.Surgical treatment of GERD may be called anti-reflux surgery. Such anoperation is called fundoplication which is done to stop the reflux ofacid. Such an operation involves wrapping of the upper stomach (thefundus) around the lower end of the esophagus. This wrap tightens thelower esophageal sphincter to minimize or prevent the reflux of stomachcontents into the esophagus. While this may limit acid exposure of theesophagus, it does not effect the treatment of Barrett's esophagus. Thelatest treatment modality for Barrett's esophagus includes surgicalexcision and ablative therapy via photodynamic therapy. Diagnosis asearly as possible is important to detect and minimize any cancer relatedproblems which may occur.

[0004] It is an object of the present invention to improve themethodology of treating Barrett's Esophagus; and it is a further objectof the present invention to provide a treatment for Barrett's Esophagusnot shown or suggested in the prior art.

BRIEF SUMMARY OF THE INVENTION

[0005] The present invention relates to laser apparatus for providingendoscopic laser treatments for dealing with abnormal mucosal tissue,particularly esophageal dysplasia, otherwise known as Barrett'sEsophagus, utilizing a delivery apparatus, for example, a laser deliveryapparatus, to permit clear visualization of the esophagus, eliminatingor reducing reflux during that visualization process, delivering a laseror other treatment of the esophagus, and reducing the movement of theesophageal wall to permit accurate laser dosimetry.

[0006] A clear balloon in the present invention is inflated when nearthe lesion in the esophagus to permit the visualization therethrough.Laser energy is transmitted through that balloon subsequent to thevisualization and targeting of a lesion thereby. A balloon which ispositioned in the lower esophagus is inflated to distend and partiallyor completely seal the esophagus from the stomach. Any reflux is keptout of the visualization field by the balloon. The lesion may be seenthrough the balloon and outside thereof by an endoscope arranged withinthat balloon. The laser treatment beam from the laser apparatus may bepositioned within that balloon upon detection of the lesion target.

[0007] A flexible endoscope with a working channel would be utilized tointroduce a balloon and a laser delivery optical fiber to be insertedwithin the patient's esophagus. The endoscope would be pressed againstthe distal end of the balloon. The scope would be utilized to permitvisualization and guidance of the balloon. Once within the desiredlocation of the esophagus, the balloon would be inflated with a fluidsuch as saline, water or a gas or the like, and the scope would beretracted to a position within the inflated balloon. The visualizationscope and a laser fiber may be steered to the appropriate spot, andlasing would be permitted through the balloon wall. Air and or otherfluid may be purged from the balloon by pumping in a saline fluidthrough the fiber-working channel and removing the air through the scopesheath annulus.

[0008] Because laser energy has an inherent selectivity to heat thetarget tissue (vasculature) and not the surrounding tissue, it is notnecessary to precisely target the lesion separate from its normalborders. In one preferred embodiment the laser light may be directedtowards the general area of treatment, bathing both normal and abnormaltissues, with the precision targeting in this embodiment left to theselective nature of the laser apparatus. In this embodiment, it ispossible to do a procedure without direct visualization: i.e.Introducing the laser delivery fiber and expose the entire lumen. Thismethod may be referred to as the “blind” procedure. A balloon wouldstill be utilized for opening up and blocking the esophagus to enhancethe coupling of laser energy to the esophageal wall with more controlleddosimetry.

[0009] A balloon of this type would have an inflated diameter of between10 to 40 mm. Alternatively, the balloon could be elastic and a change inpressure of the saline or of the air in the balloon will proportionatelychange the diameter of the balloon. The balloon in its deflated stateand its associated sheath must be less than about six mm in diameter tofacilitate passage through the nasal cavity. The balloon would have apreferred length of between 5 to 50 mm. The balloon in a furtherembodiment may have a window tip to ensure proper visualization of theentry process during insertion of the balloon into the esophagus. Thetip of the balloon may serve an anchor within the esophageal sphincter.In another embodiment, no separate tip is required and the balloon issimply stretched over the imaging optics and laser through the balloonafter the balloon has been inflated. Such an arrangement would permitlasing in the distal direction through the distal portion of the balloonin addition to lasing through the transparent walls of the balloon.Utilizing a bare tip optical fiber, the entire circumference of thesphincter, shaped as a forward hemisphere may be exposed to the laserfor treatment thereof, as well as its sidewalls through a steering scopeand laser delivery fiber at an angle which deviates from thelongitudinal axis of its sheath. Optical fibers for laser delivery mayalso be utilized in a side firing configuration, to permit better accessto the lesions along the esophageal wall not in the axis of thevisualization of the endoscope. The sheath may have further lumens orchannels therein to be utilized for irrigation and/or aspiration of thespace around the scope and the balloon, if necessary.

[0010] The use of such a balloon in the esophageal channel permits thepurging displacement of esophageal contents “out of the way” so as tosmooth the walls thereof by the balloon expansion, for improvedvisualization and lasing treatment of those esophageal walls. Theballoon in a further embodiment, may be filled with a clear fluid (gasor liquid) to permit scattering of the treatment laser light in thatballoon for the application of that treatment light onto lesions knownas Barrett's Esophagus. After visualization determines the presence ofBarrett's tissue, the clear fluid may be purged and replaced with alight scattering (dispersing) fluid for example, a non-toxic lipid. Theselective nature of the laser may then be exploited as previouslydescribed in the “blind” procedure where all the tissue is bathed inlight and the selective absorption and pulse duration guide theprecision of ‘where and how’ the laser energy is absorbed.

[0011] Another preferred embodiment of the present invention may includethe use of a radiopaque component as part of the balloon to position theballoon when fluoroscopy and not direct optical visualization is beingutilized. Once the arrangement is properly positioned, the “blind”procedure may be utilized.

[0012] The particular pathologic tissue is affected primarily by aparticular laser light energy source. The vascular component of thetissue is to be targeted and ideally, the energy from that source shouldbe specifically absorbed by the vasculature or its components. In onesuch preferred embodiment, such laser light energy may preferablycomprise a laser vascular-specific wave length of for example about520-650 nm, preferably 585 nm, with a pulse width of for example,between 0.2 and 100 ms, and a laser energy of for example, about 0.5 to8.0 joules and repetition rates of utilized since it is flexible enoughto go down an endoscope and big enough to couple a multimode laser.

[0013] Treatment energies of between about 0.5 and 1.0 Joules per pulseare typical because the area of exposure is small and the divergence isalso small. A fluence of around 30+ or − thirty J per square centimeteris considered to be ideal. Lasing ahead and to the side of a balloon anangle of about 45 degrees is one preferred method, because it permitsvisualization in a proper manner. The outside diameter of the tip of theoptical fiber must be smaller than the working channel of the scope,which is between 1 and 5 mm. The divergence of the beam of laser lightshould be optimized to match the surgical environment, ease of use anddesired spot size. The choice of fluid in the balloon will permitcontrol of divergence due to refractive index differences between thefiber and the fluid. For example, water may be utilized to decrease thedivergence of the beam due to index matching.

[0014] In a preferred embodiment, a 600 um core fiber that launcheslaser light in air at a deflection angle of about 70 degrees to thefiber axis and with divergence of approximately of about 12 degrees at ahalf angle. Such divergence may be asymmetric. The deflection angle maybe any value between 0 and 180 degrees which optimizes one or both ofthe surgical goals of treatment and visualization. This would permitoptimized visualization for a given combination of fiber and endoscopewhile getting the treatment spot optimized as well. A further embodimentis one which optimizes the divergence of the laser light to work withany index media inside the balloon in order to obtain the goals of thetreatment.

[0015] The invention thus comprises a method of treating an esophageallesion by inserting an inflatable balloon within the esophagus, theesophagus having a wall portion: inflating the balloon; and energizing alaser within the balloon to initiate a treatment of a lesion on the wallof the esophagus. The method may also include one or more of the stepsand not necessarily in sequential order: inflating the balloon with afluid such as for example a gas or a liquid; removing fluid from theballoon; treating the lesion by a light transmitted through a wall ofsaid balloon with or without direct visualization; exposing the lesionwith laser radiation through a wall of the inflated balloon; filling theballoon with a laser light-dispersal fluid; visualizing the lesionthrough the balloon; articulating the fiber to direct the laser beam ona wall of the balloon and the wall of the esophagus; placing theendoscope into the balloon prior to introduction into the patient.Another embodiment may include one or more of the following stepsincluding: placing the balloon on a distal end of an endoscope;inserting the endoscope into an esophagus to be treated; inflating theballoon with a pressurized fluid against the wall of the esophagus;placing a plurality of laser fibers or lumens through the endoscope fortreatment of the lesions in the esophagus; purging the esophagus byinflating the balloon against the wall of the esophagus to permittreatment thereof; steering the laser towards a lesion of the esophagus;the fluid may be a liquid or a gas; the liquid may be saline; theballoon preferably has an optically transparent wall; an opticallytransparent wall of the balloon is preferably in a distalmost positionthereon; the balloon may have a distalmost end having a transparentwindow thereon.

[0016] The invention may also comprise an apparatus for the treatment ofBarrett's esophagus, including: an endoscope for insertion within aninflatable balloon for insertion into the esophagus; a laser fiberapparatus for insertion within the balloon in the esophagus; and aballoon inflation/deflation means in fluid communication with theballoon for inflating and deflating the balloon. The laser fiberapparatus may be a side emitting laser fiber. A sheath may be arrangedfor supporting the endoscope. The laser fiber apparatus may be movable.A laser light source is included for generating laser energy comprisinga laser light of wave length of about 585 nm and a pulse width of about0.4 ms. And a laser energy of for example, about 0.5 to about 8.0 jouleswith repetition rates of about 1-10 Hz.

[0017] The invention may also comprise an apparatus for the treatment ofBarrett's esophagus, including: an inflatable balloon for insertion intothe esophagus; an endoscope for receipt of the balloon; a laser fiberapparatus for insertion within the balloon in the esophagus; and aballoon inflation/deflation means in fluid communication with theballoon for inflating and emptying the balloon. The laser fiberapparatus may be a side emitting laser fiber. A sheath is arranged forsupporting the endoscope. The laser fiber apparatus is movable. A laserlight source generates a laser wave length of preferably about 585 nm,and a pulse width of about 0.4 ms, and a laser energy of for example,about 0.5 to 8.0 joules and repetition rates of about 1-10 Hz.

[0018] The invention may also comprise an apparatus for occluding theesophagus distal to the treatment area. In one preferred embodiment, aballoon would be inserted into the patient and inflated so as to preventthe stomach from communication with the treatment area. Once inflated,the esophagus walls may be treated with a laser apparatus either throughdirect visualization or through the “blind” technique. The occludingarrangement may be a balloon filled with a fluid such as air or saline,or the occluding arrangement may be a mechanical umbrella-like mechanismwhich is permitted to expand once it is in the treatment area. After theesophagus has been treated, such a mechanical device would be collapsedand withdrawn from the patient. A yet further embodiment comprises anoccluding device which is bioabsorbable, such that after it has beenplaced in the esophagus and activiated to block the esophagus, thedevice may be pushed into the stomach after a procedure has beencompleted.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The objects and advantages of the present invention will becomemore apparent when viewed in conjunction with the following drawings inwhich:

[0020]FIG. 1A shows a perspective view of a balloon on the distalmostend of a sheath with a scope arranged therewithin;

[0021]FIG. 1B shows the balloon of FIG. 1 inflated;

[0022]FIG. 2A shows a balloon on a sheath with a distal tip having ascope arranged thereat;

[0023]FIG. 2B is a view of the balloon with a scope at its innermostportion while the balloon is inflated;

[0024]FIG. 3 is the inflated balloon with its distal extended tip andits fiber-optic cable lasing light through a side portion of theballoon;

[0025]FIG. 4 is a perspective view of an inflated balloon on a sheathhaving a number of working channels therewith;

[0026]FIG. 4A is a sectional view taken in FIG. 4;

[0027]FIG. 5A is a view of an inflated balloon on the distal end of asheath with a side emitting laser fiber therewith;

[0028]FIG. 5B is a perspective view of a multiple Luer lock arrangementfor servicing the inflatable balloon arrangement;

[0029]FIG. 6 is a side elevational view of a scope and optical fiber inthe sphincter and the lumen of an esophagus;

[0030]FIG. 7 is a further view of a balloon and fiber firing laser lightonto a spot on a vascular lesion;

[0031]FIG. 8 is a view of a rotating optical arrangement for redirectinglaser light;

[0032]FIG. 9 is a side elevational view of a fiber showing its workingdistance and directionality of a beam therefrom;

[0033]FIG. 10 is a side elevational view of the dimensions of apreferred embodiment of the side firing fiber tip;

[0034]FIG. 11 is an elevational view, partially in section, of atemporary occlusion arrangement for use in treating an esophagus;

[0035]FIG. 12 is a view, similar to FIG. 11, showing the occlusionarrangement in a further step in the esophagus;

[0036]FIG. 13 is an elevational view, partially in section, of a furtherembodiment of an occlusion arrangement for treating an esophagus;

[0037]FIG. 14 is a view similar to FIG. 13, showing the furtherocclusion arrangement in its fully disposed configuration; and

[0038]FIG. 15 is an elevation view, partially in section, showing anocclusion arrangement for treating an esophagus in a still furtherembodiment

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] Referring now to the drawings in detail, and particularly to FIG.1A, there is shown an esophageal treating laser apparatus 10 forproviding endoscopic laser treatments for dealing with esophagealdysplasia, otherwise known as Barrett's Esophagus. This system utilizesthe laser delivery apparatus 10 to permit clear visualization of theesophagus “E”, represented in FIGS. 1A and 1B, eliminating or reducingreflux during that visualization process, delivering a laser oreffective treatment of that esophagus, and reducing the movement of thewall “W” of the esophagus “E” to permit accurate laser dosimetry. Thelaser apparatus 10 includes a reciprocably and rotatably movable opticalemitter 12 comprised of a flexible fiber optic cable 14 in lightcommunication with a laser light source 16. The laser delivery fiberoptic cable 14 may be comprised of an optical fiber or fibers thattransmit the laser energy generated by the light source 16 and deliverto the clinical site. The emitter 12 extends through a flexibleendoscope 18 which is inserted into a patient's esophagus “E”, asrepresented in FIGS. 1A and 1B, through a sheath 19. The endoscope maycontain a coherent optical fiber bundle, preferably for visualizationand not for delivery of the laser light. A clear or at least laserlight-transparent, inflatable/deflatable balloon 20, which may beelastic, encloses the distalmost end of the sheath 19 and the fiberoptic cable 14, as is also represented in FIGS. 1A and 1B. Laser lighttransparent refers to allowing the laser energy to pass through the wallof the balloon 20 with a minimum of attenuation thus preserving theintegrity of the balloon 20. “Clear” in this case may be defined asallowing adequate visualization through the balloon 20 to permitdifferentiation between normal and abnormal tissue. The balloon 20 is influid communication with a temperature and pressure controlled fluidsource 22 via a flexible conduit 24 extending through the endoscope 18.The fluid provided to the balloon 20 by the controlled fluid source 22may be either a light transmissive liquid or a gas, or a combinationthereof.

[0040] The procedure for one preferred embodiment of the esophagealtreating laser apparatus 10 comprises the balloon 20 being pressurizedand inflated at least partially, when the distal end of the treatmentapparatus 10 is near a treatment site or lesion “L” in the esophagus“E”, as represented in FIG. 1B, to permit an optical analysis by thedistal end of a movable flexible coherent optical fiber 26 extendingthrough the movable and flexible endoscope 18 to permit visualization ofthe wall “W”- and any lesion “L” through the wall of the inflatedballoon 20. The visualization fiber 26 has a proximal end attached to aneyepiece 28 and/or a computer video analyzer 30 to permit determinationof the physical condition of the wall “W” of the esophagus “E”. After aneed determination is made of the condition of the wall “W”, the lightsource 16 creates a laser energy output to be transmitted via the opticcable 14 and out the emitter 12, through the wall of the balloon 20subsequent to the visualization and targeting of a lesion “L” thereby.The balloon 20 in position in the lower esophagus, is inflated, asrepresented in FIG. 1B, to distend and partially or completely seal theesophagus “E” from the adjacent stomach. Any reflux is thus kept out ofthe visualization field by the balloon 20, and any residual material isalso pressed away by the balloon 20 being inflated against the wall “W”of the esophagus “E”. The lesion “L” may be visualized through theballoon 20 and outside thereof by the visualization fiber 26 in theendoscope 18 arranged within the balloon 22. A laser treatment beam 34may then be directed through the balloon 20 upon detection of the lesiontarget “L”, as represented in FIG. 1B.

[0041] In a further embodiment as shown in FIGS. 2A and 2B, a flexible,directable endoscope 36 may be utilized through its working channel topermit a balloon 38 and a tip of an endoscope 40 to be inserted withinthe patient's esophagus, wherein the scope 40 would be pressabledirectly against the distal end of the balloon 38, as represented inphantom lines in FIGS. 2A and 2B, and also in as endoscope 18, asrepresented in FIG. 1A. The endoscope 18 or 40, would be utilized topermit visualization and guidance of the balloon 20/38, as representedfor example, in FIGS. 1A and 2A. The balloon 20 is required to bedeflated to pass through the narrow anatomy of the nasal passages. Thecollapsed balloon 20 or 38, would be furled, folded or stretched overthe sheath 19, and should not be larger than about 5×7 mm in crosssection with smaller sizes preferred. Once within the desired locationof the esophagus, the balloon 20/38 would be inflated with a fluid suchas saline, water or a gas or the like, as represented in FIG. 1A, andthe endoscope 36 would be retracted in the sheath 19 to a more“proximal” position within the inflated balloon, as represented in theFIG. 2B. The visualization port 44 and a laser fiber 46 may each beindividually steered or collectively steered by the endoscope 36 to theappropriate spot, and laser light would be permitted through the wall ofthe balloon 38, as represented in FIG. 3.

[0042] A further preferred embodiment of the present invention utilizesair and/or other fluid being purged from the balloon 38 by pumping in asaline fluid through a fiber working channel 48 on the sheath 19,proximal to and outside of the balloon 38 and a further lumen 50 incommunication with the interior of the balloon 38, as represented inFIG. 4, to permit removal of the fluid/gas through the endoscope 36sheath annulus. Such a sheath 19 to effect this preferred embodiment,has a proximal end represented in FIG. 5B, having a scope conduit 58 andan optic lumen conduit 60, with a saline connector 62 arranged with theconduit 58 and the optic lumen 60. The saline or other fluid mediapermits proper visualization without condensation or fogging of theimage. The fluid may also serve as a heat sink to remove unwanted andpotentially harmful thermal components induced into the balloon or thetissue by the laser energy. The fluid media may also serve to modify thedivergence of a laser beam within the balloon 20.

[0043] The balloon 38 in FIG. 4 is shown with an extended distalmostwindow 52, which may provide clearer light transmission or engagement bythe distalmost end of the endoscope 36 for more perfect directionalityor steering of the assembly 10. A balloon 38 of this type would have aninflated diameter of between about ten to about 40 mm. The balloon 38 inits deflated state, as represented in FIGS. 1A and 2A and its associatedsheath 19 must be about six mm in diameter. The balloon 38 would have apreferred length of between 5 to 50 mm, as represented by “LI” in FIGS.9 and 10. This balloon 38 may have its distal window 52 to also ensureproper visualization of the entry process during insertion of theassembly 10, including the movement of the balloon 38 into theesophagus. The extended window 52 of the balloon 38 may serve an anchorwithin the esophageal sphincter “ES”, as represented in FIG. 6. Such anarrangement would permit lasing in the distal direction through thedistal portion of the balloon 38, or permit sidewise lasing utilizing aside firing laser fiber 54, as represented in FIGS. 5A and 6, in afurther embodiment thereof.

[0044] Utilizing a bare tip optical fiber 70, as represented in FIG. 7,the entire circumference of the esophageal sphincter “ES”, shaped as aforward hemisphere may be exposed to the laser for treatment thereof, aswell as its sidewalls through a steering endoscope 72 and fiber 70 at anangle which deviates from the longitudinal axis “X” of the endoscope 72and its sheath 19. An arrangement of optical fibers 54 for lasing may beutilized also in a side firing configuration, as represented in FIGS.5A, and 6, as side firing optical fiber 76 and 9, to permit betteraccess to the lesions “L” in the wall “W” of the esophagus “E”. Thesheath 19 may have further lumens or channels 48 and 50 therein to beutilized for irrigation and/or aspiration of the space around theendoscope 36, as represented in FIGS. 4, 4A, and 5A.

[0045] The use of such a balloon in the esophageal channel permits thepurging displacement of esophageal contents “out of the way” so as tosmooth the walls thereof by the balloon expansion, for improvedvisualization and lasing treatment of those esophageal walls. Theballoon in a further embodiment, may be filled with a clear fluid (gasor liquid), for example as shown in FIGS. 5A and 7, to permit dispersingof the treatment laser light in that balloon 38 for the application ofthat treatment light onto lesions we characterize as Barrett'sEsophagus. Such a dispersing fluid may for example be a non-toxic lipid.

[0046] The particular pathologic tissue is effected primarily by aparticular laser light. Laser light specifically tuned to match thetarget's characteristics are based on the theory of “selectivethermolysis”. In one such preferred embodiment, a pulsed dye laser has awavelength that is tuned to a hemoglobin peak in blood, and its pulseduration is matched to the specific size of the blood vessels. In thisway, heat is directed to the vessel wall in an optimal manner, keepingthe surrounding tissue unaffected by the localized highly specifictargeted tissue receiving thermal treatment. In one such preferredembodiment, such laser light may preferably comprise a laser wave lengthof for example about 585 mm, with a pulse width of for example, about0.4 ms, and a laser energy of for example, about 0.5 to 8.0 joules andrepetition rates of about 1-10 Hz. A 600 um optical fiber is preferredsince it is flexible enough to go down on endoscope and big enough tocouple a multimode laser, as may be presented in FIG. 1A. Smaller fiberswill permit still greater flexibility.

[0047] Treatment energies of between about 0.5 and 1.0 Joules per pulse(8.0 Joules is available from the laser) because the area of exposure issmall and the divergence is also small. A fluence of around 30+ or −twenty J per square centimeter is considered to be ideal. Lasing aheadand to the side of a balloon an angle of about 45 degrees is onepreferred method, because it permits visualization in a more propermanner. The outside diameter of the tip of the optical fiber cannot belarger than the working channel of the scope, which is about 2.2 mm. Inone preferred embodiment, the divergence of the beam of laser lightshould be optimized to speed up the procedure of exposing the lesion andexploit the selective nature of the pulsed dye laser.

[0048] A further preferred embodiment of the optical of the fiber coreis about 600 um which launches laser light in air at a deflection angleof about 45 degrees with a divergence maximized to be between about 10to 90 degrees, as represented in FIG. 3. The divergence may beasymmetric. This would permit optmun visualization for a fiber andendoscope combination while getting the treatment spot optimized aswell.

[0049] A further embodiment of the optical core fiber is one at about600 um which launches laser light in saline at a deflection angle ofabout 45 degrees with it divergence maximized to be about 20 degrees, asrepresented in FIG. 9. A divergence member 80, is shown in FIG. 8,characterized as a rotating reflective member such as for example, amulti-mirror sphere, for deflection of a laser beam 82 from a laserlight bearing optic cable 84 would be desired, if such a rotatabledeflective member 80 could be arranged at the end of an endoscope 36.

[0050] Occlusion of the esophagus may be necessary prior to and duringthe laser treatment thereof, to permit the esophagus to be cleared andflushed to improve visualization during that treatment period, and toblock reflux and/or inflation of the stomach by insufflation.

[0051]FIG. 11 represents a procedure wherein a treatment endoscope 100is extended into an esophagus “E” to be visualized and treated. Anumbrella-like occluder 102 is extended on a multi-shaft control rod 104,from a lumen 106 in the distal end of the endoscope 100. The occluder102 is caused to “open” and occlude the neck of the esophagus, asrepresented in FIG. 12. An optical fiber 108 is arranged to extend froma further lumen 110 in the endoscope 100, and lase and thus treat alesion “L” on the wall “W” of the esophagus “E” as shown in FIG. 12. Theumbrella-like occluder 102 may be subsequently collapsed and folded upand retracted back into its lumen 106 for withdrawal from the esophagus.

[0052] A further embodiment of this occlusion treatment is shown in FIG.13, wherein a microcatheter 112 is shown extending from a lumen 114 inthe endoscope 100, which catheter 112 has a deflated balloon 116 on itsdistalmost end. FIG. 14 represents the balloon 116 being inflatedthrough its catheter 112, and being disposed in the neck of theesophagus to occlude it, preventing reflux or stomach inflation. Anoptical fiber 118 is shown extending from a further lumen 120 in theendoscope 100 to lase and treat a lesion “L” on the esophagus wall “W”.

[0053]FIG. 16 discloses a still further embodiment of an esophagealocclusion arrangement wherein an endoscope 100 has deposited abioabsorbable or digestable temporary occlusive material 122 totemporarily lodge in the neck of the lower esophagus 124. The endoscope100 would then lase any lesion by optical means, not shown for clarity,withdrawing from the esophagus, when through, leaving the temporarilyocclusive material 122 to dissolve, be digested or pass through the GItract in due course. Such occlusive arrangements discussed hereinabovemay be arranged to extend from a lumen on a side of the endoscope 100,while permitting the balloon of the earlier embodiments to be arrangedon the distal end of that scope 100.

[0054] Thus what has been shown is a unique array of apparatus andmethodologies for visualization and subsequent treatment of an esophagusnot shown or suggested in the art.

We claim:
 1. A method of treating an esophageal lesion by inserting aninflatable balloon within the esophagus, said esophagus having a wallportion, the method including: placing an optical fiber in said ballooninflating said balloon; and transmitting laser energy through said fiberwithin said balloon to effect laser radiation treatment of a lesion onsaid wall of the esophagus adjacent said balloon.
 2. The method of claim1 including: inflating said balloon with a fluid.
 3. The method of claim2 including: cooling said fluid in said balloon.
 4. The method of claim2 including: removing said fluid from said balloon.
 5. The method ofclaim 2 including: treating said lesion by a light transmitted through awall of said balloon.
 6. The method of claim 1, including: emitting saidlaser radiation through a wall of said inflated balloon.
 7. The methodof claim 2, including: filling said balloon with a laser light-dispersalfluid.
 8. The method of claim 1, including: visualizing said lesionthrough a scope arranged in said balloon.
 9. The method of claim 1,including: articulating said fiber to direct laser light on a wall ofsaid balloon and said wall of said esophagus.
 10. The method of claim 1,including: placing said balloon on a distal end of an endoscope.
 11. Themethod of claim 1, including: placing an endoscope within said balloon.12. The method of claim 10, including: inserting said endoscope into anesophagus to be treated.
 13. The method of claim 10, including:inflating said balloon with a pressurized fluid to expand said balloonagainst said wall of the esophagus.
 14. The method of claim 10,including: placing a plurality of laser fibers through said endoscopefor treatment of said lesions in the esophagus.
 15. The method of claim11, including: purging the esophagus by inflating said balloon againstsaid wall of the esophagus to permit treatment thereof.
 16. The methodof claim 1, including: steering said fiber towards a lesion of theesophagus.
 17. The method of claim 2, wherein said fluid is a liquid ora gas.
 18. The method of claim 17, wherein said liquid is saline. 19.The method of claim 1, wherein said balloon has an optically transparentwall.
 20. The method of claim 19, wherein said optically transparentwall of said balloon is in a distalmost position of said balloon. 21.The method of claim 1, wherein said balloon has a distalmost end havinga transparent window thereon.
 22. The method of claim 1, wherein saidlaser generates a laser light wavelength of about 520-650 nm and a pulsewidth of about 0.2-100 ms.
 23. The method of claim 22, wherein saidlaser has an energy of about 0.5 to about 8.0 joules and repetitionrates of about 1-10 HZ.
 24. Apparatus for the treatment of esophageallesions, including: an inflatable balloon for insertion into theesophagus; an endoscope for receipt of said balloon and introduction ofsaid balloon into the esophagus; an optical fiber apparatus forinsertion within said balloon in the esophagus; and a ballooninflation/deflation means in fluid communication with said balloon forinflating and emptying said balloon of a fluid.
 25. The apparatus asrecited in claim 24, wherein said fiber apparatus is a side emittinglaser fiber.
 26. The apparatus as recited in claim 24, including asheath for supporting said endoscope.
 27. The apparatus as recited inclaim 24, wherein said optical fiber apparatus is movable and steerable.28. The apparatus as recited in claim 23, including a laser light sourcegenerating a laser wave length of about 520-650 nm, and a pulse width ofabout 0.2-100 ms, and a laser energy of about 0.5 to 8.0 joules andrepetition rates of about 1-10 Hz.
 29. The apparatus as recited in claim24 having a portion thereof radio-opaque so as to be visible underfluoroscopy.
 30. Apparatus for the treatment of esophageal lesions,including: an endoscope for insertion into the esophagus; an occlusiondevice movably arranged in a distal end of said endoscope fortemporarily occluding a lower portion of said esophagus; and a laserfiber apparatus movable arranged through said distal end of saidendoscope.
 31. The apparatus as recited in claim 30, wherein saidocclusion device comprises an umbrella-like member which is openable andclosable by control means arranged through a lumen in said endoscope.32. The apparatus as recited in claim 30, wherein said occlusion devicecomprises an inflatable balloon which is inflatable and deflatablethrough a microcatheter arranged through a lumen in said endoscope. 33.The apparatus as recited in claim 30, wherein said occlusion devicecomprises a biodegradble or digestable material disposably arranged onthe distal end of said endoscope and into a lower end of said esophagus.34. A method of treatment of Barrett's esophagus, including: insertingan endoscope for insertion into the esophagus; arranging an occlusiondevice movable in a distal end of said endoscope for temporarilyoccluding a lower portion of said esophagus distal to a treatment areatherein; moving a laser fiber apparatus through said distal end of saidendoscope; and aiming and energizing said laser via a laser deliveryfiber onto a lesion on a wall portion of said esophagus.
 35. The methodas recited in claim 34, wherein said occlusion device comprises anumbrella-like member which is openable and closable by control meansarranged through a lumen in said endoscope.
 36. The method as recited inclaim 34, wherein said occlusion device comprises an inflatable balloonwhich is inflatable and deflatable through a microcatheter arrangedthrough a lumen in said endoscope.
 37. The method as recited in claim34, wherein said occlusion device comprises a bioabsorbable ordigestable material disposed from said distal end of said endoscope andinto a lower end of said esophagus.